TriangleNCT01546038 · OUTCOME
Baseline mRNA Levels Associated With Best Overall Response at Phase 2 Unfit
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Normalized expression units
- Interval / dispersion
- Full Range
- Time frame
- Baseline (Cycle 1/Day 1 pre-dose)
What was measured
Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. Whole blood mRNA analyses were performed on 21 mRNA candidates. Baseline mRNA level showing statistically significant correlation with clinical response are reported. FOXM1: Forkhead box M1; PTCH1: Patched 1.
Analysis population: PD analysis set:all enrolled participants in Phase 2 Unfit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.
Groups in this outcome
Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)
AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)
AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
| Group | Source count |
|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder) | 33 |
| Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder) | 55 |
Reported measurements
FOXM1
| Group | Source count |
|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder) | 15 |
| Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder) | 28 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder) | 0.20 | Not reported | 0.05 | 0.77 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder) | 0.40 | Not reported | 0.09 | 1.86 | Not reported |
PTCH1
| Group | Source count |
|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder) | 14 |
| Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder) | 27 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder) | 0.20 | Not reported | 0.07 | 0.58 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder) | 0.10 | Not reported | 0.01 | 0.42 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.05
- upper Limit
- 0.77
- value
- 0.20
- group Id
- OG001
- lower Limit
- 0.09
- upper Limit
- 1.86
- value
- 0.40
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 28
- units
- Participants
- title
- FOXM1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.07
- upper Limit
- 0.58
- value
- 0.20
- group Id
- OG001
- lower Limit
- 0.01
- upper Limit
- 0.42
- value
- 0.10
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 27
- units
- Participants
- title
- PTCH1
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 55
- units
- Participants
- description
- Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. Whole blood mRNA analyses were performed on 21 mRNA candidates. Baseline mRNA level showing statistically significant correlation with clinical response are reported. FOXM1: Forkhead box M1; PTCH1: Patched 1.
- dispersion Type
- Full Range
- groups
- description
- AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
- id
- OG000
- title
- Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)
- description
- AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
- id
- OG001
- title
- Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)
- param Type
- MEDIAN
- population Description
- PD analysis set:all enrolled participants in Phase 2 Unfit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.
- reporting Status
- POSTED
- time Frame
- Baseline (Cycle 1/Day 1 pre-dose)
- title
- Baseline mRNA Levels Associated With Best Overall Response at Phase 2 Unfit
- type
- SECONDARY
- unit Of Measure
- Normalized expression units
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice